International buyers and even some Indian procurement teams sometimes assume an FDA-cleared or CE-marked X-ray machine is automatically compliant in India. It isn't. Each certification body evaluates against a different regulatory framework:

An FDA-cleared or CE-marked machine still requires separate, full AERB type approval before it can operate in India. Treat these as complementary at best, not substitutes.

How to verify an AERB certificate is genuine

Before finalizing any purchase, verify the certificate directly rather than taking a supplier's word for it:

1. Request the AERB type approval certificate and confirm it names the exact model you're purchasing — approval is model-specific, not brand-wide.

2. Cross-check the certificate details against AERB's own published registry or by contacting AERB directly.

3. Confirm the certificate is current and hasn't lapsed or been superseded by a newer approval for that model.

4. For government tenders, confirm the documentation format matches what your tender submission requires — some tenders require additional supporting paperwork beyond the certificate itself.

   
   

What happens if equipment isn't AERB-approved

Operating X-ray equipment without valid AERB approval carries real regulatory and liability exposure — for the operating facility, not just the supplier. This is one area where cutting a corner to save time or cost during procurement creates risk that lands on the buyer's institution, not the vendor's.

Frequently Asked Questions

Is AERB approval mandatory for all portable X-ray machines in India?

Yes. Any X-ray equipment operated in India, portable or fixed, requires valid AERB type approval regardless of manufacturer or country of origin.

Does an FDA-cleared or CE-marked X-ray machine need separate AERB approval to operate in India?

Yes. FDA and CE certifications are not recognized as substitutes for AERB approval — a separate, full AERB certification process is required.

How can I verify a supplier's AERB certificate is genuine and current?

Request the model-specific certificate and cross-check it against AERB's official registry or by contacting AERB directly, rather than relying solely on the supplier's documentation.

What are the risks of using non-AERB-approved X-ray equipment?

Operating uncertified equipment creates direct regulatory and liability exposure for the operating facility, separate from any issue with the equipment itself.